MAUDE Adverse Event Report: JARIT GMBH/ INTER LIFESCIENCES CORPORATION JARIT 260-504 MICROFRANCE; MILTEX; PADGETT; RUGGLES REDMOND XOMED; RONGEUR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2018

Event Type  Injury  

Event Description

Surgical tech noted that a screw (measured about 5 mm in diameter and several 8 mm in length) was missing from the jarit 260-504 ronguer during a hip arthroplasty surgery.An xray was taken to confirm the screw had fallen into the posterior soft tissues.

• Brand Name: JARIT 260-504 MICROFRANCE; MILTEX; PADGETT; RUGGLES REDMOND XOMED
• Type of Device: RONGEUR
• Manufacturer (Section D): JARIT GMBH/ INTER LIFESCIENCES CORPORATION; DE
• MDR Report Key: 8176326
• MDR Text Key: 131219747
• Report Number: MW5082255
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 102